Manager, Complaints Engineering

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We are committed to reducing our environmental impact both in our own operations and across the value chain. We operate with a global perspective on sustainability guided by the precautionary principle and in collaboration with our key stakeholders. Our key initiatives and principles are Greenhouse emissions, Resource efficiency, Circularity and Eco-Design. We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

We currently have an open position for a Manager Complaint Engineering.

Key Responsibilities:

Design or plan pro Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements. Manage the Complaints Engineering responsibilities for product areas. Lead efforts for complaint engineering compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards. Ensure the return sample investigation test methods are established and validated. Ensure timely and accurate investigations of returned products to support effective complaint closures. Prepare complaint data for Monthly Metrics & Management Reviews and lead the review and discussion of the data. Supervise and coordinate efforts of the complaint engineering team to assure proper product quality trending. Support and own CAPA investigations to address complaint triggers and events. Support Post Market Surveillance (PMS) activities. Generate reports and provide necessary information for Health Hazard Evaluations (HHEs) and Field Actions. Ensure alignment of risk categories in complaints with the risk management files.

Requirements:

Required skills and experience:

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  RequiresBachelor's degree in Engineeringor a related field plus 5 years of experience in complaints, engineering, or related

  
  
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  1 year of supervisory experience for product quality trending;

  
  
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  Knowledge and experience working with quality systems per 21 CFR 820, 21 CFR 803, ISO 13485, MEDDEV 2 12-1 (93/42/EEC), EUMDR, and other related regulations and standards;

  
  
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  Familiarity with electronic complaints systems and understanding of the complaint handling process;

  
  
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  Ability to practice good safety standards and returned products safe handling techniques including ability to handle biohazards material as per OSHA guidelines;

  
  
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  Product knowledge on failure analysis;

  
  
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  Proficiency with Microsoft Office Word, Excel, Visio, Power Point, or equivalent software applications.

  
  
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  Ability to handle Biohazards material as per OSHA guidelines;

  
  
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  Experience evaluating and analyzing data or information to solve problems (i.e. analyzing the trend to determine if an action needs to be taken for redesign); and

  
  
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  Monitor processes and analyze data to interpret the meaning of the information (i.e. reaching out to supplier to correct, identify customer training issues, and work with operations to review our processes).

  
  

The Base Salary for this position is a minimum of $ 124,000 and a maximum of $155,000 plus 15% annual bonus

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.